End Of Life; Regulatory Requirements - ACteon Sopro 717 First Manuel D'utilisation

E N G L I S H
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REGULATORY REQUIREMENTS

4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an authorized quality system. It meets the
European directive 93/42/EEC requirements relative to medical devices. Therefore, it particularly meets electrical
safety and electromagnetic compatibility standards (IEC) (CEM).
4.2. ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements to correctly interact in an electronic
environment. Although this dental camera system was designed according to this compatibility and complies with
the electromagnetic interference thresholds established by the regulatory agency, there is no guarantee about
interference likely to occur on a particular installation.
If the device generates interference with radio communication services (which can be determined by switching it
off and on), the user is recommended to try to correct this phenomenon by taking whole or part of the following
measures:
• Change the receiving antenna orientation
• Reposition the product according to the receiver.
• Take the computer away from the receiver.
The SOPRO 717 First camera is designed and tested to be used in a home environment, class B Group 1, according
to CISPR11 standard.
4.3. MEDICAL DEVICE VIGILANCE
As any medical device, this device is subjected to the medical device vigilance dispositions; any serious dysfunction
should then be the subject of a description to the competent authorities and to the manufacturer as soon as possible
and as precisely as possible.

4.4. END OF LIFE

This device bears the recycling symbol according to the European directive 2002/96/EC about electric and
electronic equipment waste (DEEE or WEEE). By correctly disposing of this device, you will contribute to avoiding
any damage to the environment and human health.
The symbol present on the device or on the accompanying documentation indicates this product cannot be, in any
case, treated as household waste. Therefore, it should be transferred to a waste collection center that handles
electric and electronic equipment recycling.
Respect the standards relative to waste disposal in force in the installation country. For more details about the
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